Non-Abstinence Outcomes in Methamphetamine Use Disorder (RCT (05))

Advancing Non-Abstinence Outcomes in the Treatment of Methamphetamine Use Disorder

Reduced drug use is a clinically meaningful target for treatment development, but few studies have evaluated the positive impacts produced by this behavioral change, preventing adoption of this endpoint in clinical trials. The proposed research will fill that critical knowledge gap by demonstrating the biopsychosocial benefits of reduced methamphetamine use. These data will be used to change current accepted methamphetamine treatment endpoints and accelerate identification of therapies for methamphetamine use disorder.

Study Overview

• Status: Recruiting
• Conditions: Methamphetamine Use Disorder
• Intervention / Treatment: Behavioral: Contingency Management

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: William W Stoops, PhD; Phone Number: 8592575388; Email: william.stoops@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40507
      • Recruiting
      • Psychopharmacology of Addiction Laboratory
      • Contact: William W Stoops, PhD; Phone Number: 859-257-5388; Email: william.stoops@uky.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• be age 18 years or older;
• self-report methamphetamine use in the week prior to screening;
• provide a methamphetamine-positive urine sample at screening;
• meet DSM-5 criteria for moderate-severe Methamphetamine Use Disorder (MUD);
• be seeking treatment for their methamphetamine use
• be able and willing to commit to the 12-week intervention, as well as the 12-week post-intervention follow-up
• Individuals who meet these criteria and are stably maintained on buprenorphine or methadone for Opioid Use Disorder (OUD) will also be eligible to participate.

Exclusion Criteria:

• current or past medical or psychiatric illness (e.g., physical dependence on any drug other than buprenorphine requiring medically managed detoxification, unstable angina, uncontrolled cardiac arrhythmia, aortic stenosis, self-reported compromised immune function, severe diagnosis for a SUD other than MUD or treated OUD) that would interfere with study participation in the opinion of the study physicians
• poor venous access precluding blood draws

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; This group will receive payment for providing urine samples throughout the trial.
Experimental: Contingency Management Group; This group will receive payment for providing methamphetamine negative urine samples throughout the trial.	Behavioral: Contingency Management; Subjects will receive payments for providing methamphetamine negative urine samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Arterial Pressure	Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg	At baseline.
Mean Arterial Pressure	Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg	Week 1 of participation.
Mean Arterial Pressure	Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg	Week 2 of participation.
Mean Arterial Pressure	Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg	Week 3 of participation.
Mean Arterial Pressure	Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg	Week 4 of participation.
Mean Arterial Pressure	Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg	Week 5 of participation.
Mean Arterial Pressure	Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg	Week 6 of participation.
Mean Arterial Pressure	Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg	Week 7 of participation.
Mean Arterial Pressure	Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg	Week 8 of participation.
Mean Arterial Pressure	Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg	Week 8 of participation.
Mean Arterial Pressure	Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg	Week 9 of participation.
Mean Arterial Pressure	Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg	Week 10 of participation.
Mean Arterial Pressure	Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg	Week 11 of participation.
Mean Arterial Pressure	Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg	Week 12 of participation.
Endothelin-1	Endothelin-1 levels will be measured. They will be recorded in pg/ml.	At baseline.
Endothelin-1	Endothelin-1 levels will be measured. They will be recorded in pg/ml.	Week 6 of participation.
Endothelin-1	Endothelin-1 levels will be measured. They will be recorded in pg/ml.	Week 12 of participation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep	Sleep will be measured with the Pittsburgh Sleep Quality Index, with a range from 0-21 where lower scores are better.	At baseline.
Sleep	Sleep will be measured with the Pittsburgh Sleep Quality Index, with a range from 0-21 where lower scores are better.	Week 4 of participation.
Sleep	Sleep will be measured with the Pittsburgh Sleep Quality Index, with a range from 0-21 where lower scores are better.	Week 8 of participation.
Sleep	Sleep will be measured with the Pittsburgh Sleep Quality Index, with a range from 0-21 where lower scores are better.	Week 12 of participation.

Collaborators and Investigators

• Sponsor: William Stoops
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: William W Stoops, PhD, University Of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2026
• Primary Completion (Estimated): January 4, 2031
• Study Completion (Estimated): January 4, 2031

Study Registration Dates

• First Submitted: November 6, 2025
• First Submitted That Met QC Criteria: November 6, 2025
• First Posted (Actual): November 10, 2025

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: treatment; behavioral intervention; methamphetamine
• Other Study ID Numbers: 107171; R01DA064144 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant level data will be findable and identifiable using the unique number assigned to this grant application by NIDA. Where the data are available and how to access the data will be identified in any publications and presentations about these data. The repository and funding source will also be acknowledged in any publications and presentations. The Open Science Framework, which is a generalist repository, will be the data repository. This repository has policies and procedures in place that will provide data access to qualified researchers.
• IPD Sharing Time Frame: No later than one year after the completion of the funded project period. Data will be available indefinitely after that.
• IPD Sharing Access Criteria: Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) and could be used for secondary study purposes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No